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Pharmacotherapy for the Different Phenotypes of Airways Disease

In a random community sample of people 18-75 years with wheeze and dyspnea, does the response to salbutamol 400 mcg once, iprotropium 80 mcg once or budesonide 800 mcg daily for 12 weeks differ between airways disease phenotypes in lung function, disease control and quality of life?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000666022
Enrollment
16459
Registered
2010-08-16
Start date
2010-11-15
Completion date
2012-12-03
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic obstructive pulmonary disease (COPD) and asthma are the most common respiratory diseases in the community. People with these diseases differ in the way the disease manifests itself and some people have features of both diseases. We know that the best medications for asthma and COPD are different but we do not know if best treatment differs between the different types of asthma, COPD and the overlap of the two conditions. This study will answer this question by identifying people in the community with respiratory disease, assessing how the disease manifests in individuals and the effectiveness of three different standard inhaled medications. We will then group individuals into different clusters (types or patterns of disease manifestation) and determine which clusters respond to which different medication. This information will guide doctors who are treating these diseases.

Interventions

1. Ipratropium 80 mcg inhaled single dose 2.Salbutamol 400 mcg inhaled single dose 3. Budesonide 400 mcg inhaled twice daily for 12 weeks All participants will receive all interventions in the sequence 1, 2, 3. Interventions 1 and 2 to be administered 1-4 weeks apart. Intervention 3 to be administered over the 12 weeks immediately following intervention 2.

Sponsors

Medical Reseach Institute of New Zealand
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

selected at random from the electoral register wheeze and shortness of breath in the last 12 months

Exclusion criteria

Unable or unwilling to withhold medication prior to study visits. Hypersensitivity to study drug.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026